Exelixis has completed the submission of their supplemental New Drug Application (sNDA) for Cabometyx (cabozantinib) as a first line treatment for patients with previously untreated advanced renal cell carcinoma (RCC).

The sNDA submission includes results from CABOSUN, a Phase 2, open-label, active controlled trial. A total of 157 patients with previously untreated advanced RCC with intermediate- or poor-risk disease were enrolled and randomized 1:1 to receive cabozantinib (60mg once daily) or sunitinib (50mg once daily for 4 weeks followed by 2 weeks off) as first line therapies. The primary endpoint was progression-free survival (PFS).

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Results showed that the cabozantinib group had significantly increased median PFS compared to the sunitinib group with 8.2 vs. 5.6 months, respectively. Additionally, the cabozantinib group was linked to a 34% reduction in rate of progression or death (adjusted HR 0.66; 95% CI: 0.46–0.95; P=0.012). Objective response rate (ORR) was 46% for the cabozantinib group vs. 18% for the sunitinib group.

Grade 3/4 adverse events were 67% for cabozantinib and 68% for sunitinib, and included diarrhea, fatigue, hypertension, palmar-plantar erythrodysesthesia, and hematologic adverse events.

Cabometyx works by inhibiting the activity of MET, AXL and VEGFR-1, -2 and -3 receptors. It was initially approved in 2016 by the Food and Drug Administration (FDA) to treat patients with advanced RCC in patients who have received prior anti-angiogenic therapy. Cabometyx is available as 20mg, 40mg or 60mg strength tablets. 

For more information call (855) 500-3935 or visit Cabometyx.com.